President, B. Braun Central Admixture Pharmacy Services (CAPS)

Q. For your clients who have completed their gap analyses, what areas of their sterile-compounding practices have required the most change?
A. What strikes me most is the tendency of hospitals to focus on the facility issues. Building a new cleanroom is the easy part; the harder parts are issues like training, tracking, trending, and environmental monitoring. The most difficult part is changing employees’ mindsets so that they meet the new standards consistently—not just before JCAHO surveys or when someone is watching. For example, management needs to instill a culture that supports consistency; it is not okay to gown up just during the day shift and not during the evening or midnight shifts. Meeting quality standards is a priority 24 hours a day, 365 days a year, at all points of care.

Q. For those organizations that have not yet completed their gap analyses, do you have any recommendations for how they should proceed?
A. Here are some top-line actions to consider: Go to the ASHP website and use the gap analysis tool that they offer. Go through your pharmacy and do an honest assessment of where you are compliant and where you are not. Don’t look at building a $400,000 cleanroom as your first action plan. The standards are changing, and the CAPS pharmacies can prepare both patient-specific and anticipatory IV prescriptions. Joint Commission is not requiring compliance with the facility standards until 2008. For example, there is a proposal to allow compounding in sub-ISO class 5 conditions if the preparation is completely administered within a limited period of time. If this proposal goes through it could reduce the need for high-cost upgrades to existing satellite pharmacies. Other regulations are certain to change before 2008. While doing your gap analysis, look for opportunities to reduce regulatory burdens, such as premixed delivery systems or outsourcing a portion of your most difficult admixtures with a pharmacy extension like CAPS.

Q. How have USP Chapter <797> regulations affected your organization?
A. Our customers know that we already have over a decade of sterile compounding expertise. We’ve seen an increase in our business as our long-time customers have expanded their use of our services and as new customers see the benefits of outsourcing their highand medium-risk preparations, including a reduced overall compounding volume and a reduced number of tests to perform and people to train.

Q. Following the new requirements for compounding mediumand highrisk solutions can seem intimidating. At CAPS, how do you ensure complete regulatory compliance for those solutions?
A. At CAPS, prior to <797>, we had been meeting the USP Chapter <1206> standards – the precursor to <797> – since the mid 90s. Additionally, as a registered manufacturer, CAPS is regularly inspected by the FDA. We have incorporated current Good Manufacturing Practices, including many aspects of the FDA’s “Aseptic Processing” guidance recommendations, into our standard operating procedures.

Q. What benefits can be realized by pharmacies that outsource their mediumand high-risk solutions?
A. The USP standards for high-risk compounding require more rigorous testing and documentation than mediumor low-risk compounding. By eliminating high-risk compounding, pharmacies reduce specialized training needs, testing, tracking, and trending, and the costs associated with all these functions. For example, media fills are required every six months for high-risk products and every year for lowand medium-risk products. By eliminating as many mediumrisk products as possible, you reduce the overall cost of compliance. Also, the outsourcing of TPN preparation might reduce the need for one or two LAFWs (laminar air flow workbenches), one or two employees, and several thousand dollars per year in bioburden media, touch plates, tryptic soy broth, gowning and gloving, sterile alcohol, and so on. Outsourcing customers can rely on outside expertise to ensure patient safety, to improve their staff productivity, and to reduce associated costs.

Q. Compounding high-volume, low-risk preparations can be very timeconsuming. What solution does CAPS offer in this area?
A. Our focus is sterile products. We limit ourselves to sterile compounding, and we put all of our resources into doing it the best way possible. In the hospital environment, it is difficult to control the differences in personnel and settings where solutions are compounded. At CAPS, we continually test our employees and the environment, to be sure we are in compliance. For example, our employees aren’t interrupted by a phone call from a nurse who is missing a suppository; they don’t have the distractions that hospital employees do.

Q. Do you provide bar-coded labels for your clients?
A. We have a variety of standard bar code label formats our customers can choose from. Some customization is also available.

Q. Have any of your clients recently completed a JCAHO survey in which their compliance to USP Chapter <797> was evaluated?
A. JCAHO has become increasingly more stringent in regards to USP Chapter <797> compliance issues. In 2005, the key step is to have a written plan for compliance. Several large hospital clients have JCAHO surveys coming up in the very near future, and we are working in partnership with them to help them prepare their plans.

Q. A study of compounding IV admixtures, reported in AJHP and conducted across five hospitals, found that nine out of every 100 IV doses mixed in the hospital pharmacy contained at least one error, posing a substantial risk to patients (Flynn. AJHP. 1997;54). How do you manage error prevention and reduction in your organization?
A. We have a program at CAPS called CQAIP (Continuous Quality Assessment and Improvement). We track and trend environmental monitoring, media fills, training, end-product testing, assay results, delivery timeliness, and customer complaints, among other things. At CAPS, everyone is responsible for quality. We conduct monthly reviews of individual results in each pharmacy and aggregate the results quarterly at meetings attended by the management team. We continually review and update our SOPs to ensure we are making the safest, most efficacious sterile preparations possible.

Q. How do you avoid errors during/from order transmission?
A. This requires processes, people, and products to be held accountable for attaining unusually high, yet essential safety standards. CAPS uses proprietary software that is validated to meet FDA standards. Our customers enter the orders into the software in their pharmacy where compatibility, drug interaction, and dosing checks are performed. After the orders are transmitted to CAPS those checks are repeated on our end. Finally, a pharmacist scrutinizes each label before it is approved for compounding.

Q. To analyze different options for managing compounding, a health system needs to understand their baseline cost. What factors should be included in this analysis?
A. Labor is a big component, including training and recruiting, and raw materials, supplies, solutions, the cost of quality, the cost of liability, waste of materials, testing, tracking, trending, environmental monitoring, carrying cost of inventory, space utilization, and the cost of capital equipment also factor in. There are more, but you get the idea.

Q. How are materialwaste costs affected by outsourcing compounding?
A. When you outsource, you reduce your combined fixed and variable costs to 100% variable costs. You only pay for what you use. If TPN compounding is performed in five different hospitals, there will be more waste than if compounding took place in one location, because your raw material source containers will be spread over more doses.

Q. What kind of documentation should a pharmacy ask for when considering working with an outsourcing company?
A. There are five aspects that quickly come to mind. First, ask for licensing and registration documents. Ask if the company is registered with the FDA and if they have a sterile compounding pharmacy license. You should also ask if they provide quality assurance/control reports, and ask to see training documentation.

Q. How should a client measure their ROI from outsourcing their compounding?
A. The easiest way is from a pure cost-reduction standpoint. They can also have cash-flow analysis done, and examine the reductions in the carrying cost of inventory. Sophisticated hospitals might look at the redeployment of labor from sterile product preparation to clinical activities, and include cost savings based on cognitive programs related to pharmaceutical care.